Caplyta, a Johnson & Johnson drug, met its primary and key secondary endpoints in a second pivotal phase 3 trial evaluating it for manic episodes in adults with bipolar I disorder.
Study 452 found that Caplyta significantly reduced manic symptoms and overall illness severity compared with placebo at Week 3, with improvements observed as early as Day 3.
The global, randomized, double-blind study compared once-daily Caplyta 42 mg with placebo over three weeks in adults with manic episodes, with or without mixed features.
At Week 3, patients receiving Caplyta had a 3.7-point greater reduction in Young Mania Rating Scale scores than those receiving placebo. A clinical response, defined as at least a 50% improvement from baseline, was achieved by 43.9% of patients receiving Caplyta, compared with 23.7% receiving placebo.
The drug’s safety profile was consistent with previous studies. Treatment-related adverse events reported in at least 5% of Caplyta patients and at least twice the placebo rate were dizziness, dry mouth and somnolence or sedation.
The findings, combined with positive results from the earlier phase 3 Study 451, will support a planned U.S. regulatory submission. Caplyta is currently approved for bipolar depression, schizophrenia and as an adjunctive treatment for major depressive disorder, but not for bipolar mania.
The company said the two positive studies reinforce Caplyta’s potential to address both depressive and manic episodes of bipolar disorder.
